FDA 483 - Boehringer Ingelheim Animal Health do Brasil Ltda. - December 13, 2022

An FDA inspection of Boehringer Ingelheim Animal Health do Brazil Ltda. in Paulinia, Brazil, revealed significant deficiencies in their quality control unit and manufacturing processes. The firm failed to adequately investigate numerous out-of-specification results, including sterility and assay failures, and did not establish proper procedures for process validation and yield calculations. These issues indicate a systemic breakdown in ensuring product quality and compliance.